I-Ning Tang | Senior Reviewer & Team Leader
Center For Drug Evaluation | Taiwan

I-Ning Tang, Senior Reviewer & Team Leader, Center For Drug Evaluation

Dr. Tang has worked as a medical reviewer since 2010, firstly in the Taiwan Food and Drug Administration (TFDA) then in the Center for Drug Evaluation (CDE). TFDA is the competent authority in charge of food, drugs, controlled drugs, medical equipment and cosmetics related management in Taiwan; CDE was established by Department of Health (DOH, now Ministry of Health and Welfare, MOHW) in 1998, to assist the technical evaluation for market approval of drugs and medical devices. 

Dr. Tang received her M.D degree from the National Cheng Kung University, Taiwan, in 2001. After that she had practiced medicine for almost 10 years before entering the regulatory science field. She continued her education while working and received her master degree in 2010. Currently, she is a PhD candidate in the National Taiwan University (NTU), Taiwan, focusing on researches with respect to human brain networks on normal subjects and patients, and exploring possible surrogate endpoints by imaging analysis.

Since joining in the regulatory science filed, Dr. Tang has been involved in various projects. She is an experienced reviewer in evaluating market authorization application of both medical devices and drugs, also clinical trial protocols of all phases. A major part of her work at present is to provide scientific advice to domestic biotech companies, pharmaceutical companies, non-government organization and research institutes, assist government agencies such as the Ministry of Economic Affairs in evaluating biopharmaceutical industry development programs and budget, and give advice to government agencies for formulating policy and laws related to biopharmaceutical industry and trade. Besides, she is frequently invited as a speaker in different specialized topics, like clinical trial protocol design, clinical trial regulations, adverse event reporting during clinical trials, etc.

Appearances:



Phar-East Day 2 @ 14:30

Clinical trial capacity related to MRCT in Taiwan

last published: 26/Sep/18 02:35 GMT

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